NCT05972044

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.

Detailed description

Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Solriamfetol 150 mg	Solriamfetol tablets, taken once daily
DRUG	Solriamfetol 300 mg	Solriamfetol tablets, taken once daily
DRUG	Placebo	Placebo tablets, taken once daily

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-02-07
• Completion: 2025-03-14
• First posted: 2023-08-02
• Last updated: 2026-02-10

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study